The purpose of this study is to estimate the rate at which a certain population becomes infected with HIV. The individuals examined in this study are people who are expected to take part in future studies of HIV vaccines and nonvaccine HIV prevention studies. This study also examines the chances of becoming HIV-positive based on certain risk factors under conditions that are similar to the conditions that would exist in HIV vaccine and non-HIV prevention studies.

Before studying the effectiveness of a potential HIV vaccine, it is important to learn about the range of HIV risk behaviors in the potential participants of these studies. The probability of HIV infection associated with these risk behaviors should also be examined. This study is designed to increase the ability of HIVNET to put into place HIV prevention trials, to increase the diversity of trial participants, and to target populations at highest risk for HIV infection.

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:

4892

Detailed Description:

Vaccine preparedness studies are necessary in order to prepare for launching preventive HIV vaccine efficacy trials. It is important to gather information on the risk of HIV infection among recruited populations, the extent and stability of HIV risk behaviors in these populations, and the risk of HIV infection associated with risk behaviors. This vaccine preparedness study is designed to expand the capacity of the HIVNET to implement HIV prevention trials, increase the diversity of its participant population, and further target populations at highest risk of HIV infection.

Participants complete a total of 6 scheduled study visits: 2 at baseline, 2 at follow-up 6 months later, and 2 at follow-up 12 months after enrollment. Participant risk behaviors and knowledge of and attitudes toward HIV vaccine and other HIV prevention trials are assessed at each time point. HIV infection status is tested by standard HIV ELISA and Western blot at follow-up, as well as at participant request throughout the study. Participants are instructed to recognize and report suspected primary HIV infection based on symptoms or high-risk exposures. HIV pre-test, risk reduction, and post-test counseling is provided in accordance with CDC standards of practice. Participants who become infected with HIV during the study are counseled and referred for medical and psychosocial services.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria

Participants meet the following criteria:

HIV-seronegative.

Available for 6 months of the study. (Note:

Participants who plan to move from one study location to another are eligible.)

Willing and able to provide information for locator purposes.

Report one or more of the following risk behaviors:

For men:

Intravenous or intramuscular injection of any drug on an average of 3 or more days per week during the last 3 months.

Anal intercourse (receptive or insertive) with one or more other men in the last year.

For women:

Intravenous or intramuscular injection of any drug on an average of 3 or more days per week during the last 3 months.

Having a current male sex partner who is infected with HIV.

Having a current male sex partner who has injected drugs in the last 5 years.

Willing to agree to be interviewed with their partner and individually.

Willing to continue engaging in sex with their partner.

Willing to participate in a couples-based condom promotion intervention.

Willing and able to attend each scheduled intervention/follow-up study visit.

Exclusion Criteria

Co-existing Condition:

Persons with the following symptoms or conditions are excluded:

An obvious psychological or psychiatric disorder that would preclude provision of informed consent or otherwise contraindicate study participation.

Any condition which in the opinion of the principal investigator would interfere with achieving the study objectives.

Men at risk through anal intercourse only are excluded if they:

Currently have a single HIV-seronegative partner with whom they have been in a mutually monogamous relationship for at least 2 years.

Men and women at risk through injection only are excluded if they:

Have been participating in any methadone drug treatment program for at least the last 6 months.

Currently obtain over 50 percent of needles/syringes for injection of drugs from a needle exchange program.

NOTE:

Meeting the following extremely high injection risk criteria overrides the exclusion criteria for injection risk as outlined above:

Using a needle or syringe after one or more known HIV-positive persons 2 or more times in the past 3 months.

Using a needle or syringe after persons of unknown HIV status in the past 3 months provided the following two conditions are true:

(1) report using a needle or syringe after someone else 2 or more different times in the past 3 months and (2) report using a needle or syringe after 3 or more different persons in the past 3 months. (This second criterion could be met in 3 episodes of injection with a single injection partner, if the participant used a needle or syringe after a different person each time. Alternatively, the criterion could be met in a single episode of injection, if the participant used a needle or syringe after 3 or more persons had used a single set of works.)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000915